FDA Approves First Generic Cyclosporine Oral Solution for Cats for Treatment of Allergic Dermatitis

While Atopica has been approved for dermatitis in dogs and cats for many years, a generic modified cyclosporine oral solution, Modulis (Provetica, LLC) has now been approved for cats by the U.S. Food and Drug Administration. A generic equivalent to Atopica for dogs, Cyclavance, was approved in October 2020.

It is important to note that the human cyclosporine oral solution (Sandimmune) is not equivalent to Atopica, Modulis, or Cyclavance and should not be substituted. Furthermore, bioavailability studies of the human modified cyclosporine oral solution, Neoral, showed that it was not equivalent to Atopica and Cyclavance in dogs. (1) Modified cyclosporine oral solutions are best administered on an empty stomach in dogs; modified cyclosporine oral solution may be given with or without food to cats.  Read more…

(1) Navarro C, Seguy L, Vila M, Birckel P. Bioequivalence study between two formulations of ciclosporin A (Cyclavance(R) oral solution and Atopica(R) soft capsules) following a single oral administration to dogs. BMC Vet Res. 2016;12:54. doi: 10.1186/s12917-016-0669-9